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By Nicole - 23rd June, 2022 | Posted in Healthcare, Biomedical, Laboratory
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Process Challenge Devices are essential to ensure compliance with the HTM01-01 in sterile service departments within the Healthcare industry.

At Sychem, we offer a diverse range of Process Challenge devices to keep your SSD running as smoothly as possible.

What is a Process Challenge Device? 

A Process Challenge device is used to assess the effectiveness of the performance of decontamination processes, by providing a challenge that is equal to or greater than the challenge posed by the most difficult to wash/sterilise item routinely processed.

Process Challenge devices are used for validation and routine monitoring of the efficacy of cleaning and sterilisation processes.

Where can process challenge devices be used?

There are many kinds of Process Challenge devices, used to challenge processes within machines, including washers, autoclaves and other decontamination equipment.

The devices can be used in numerous industries where the decontamination equipment operates; however they are most often used in the Healthcare sector due to the regulatory nature of the HTM-01-01.

PCD- Cleaning Indicators

Cleaning Indicators are required to monitor the effectiveness of cleaning processes within washer disinfectors. Cleaning Indicators can be used in various sectors, including Laboratory, Dental, Life Science and Healthcare.

Used for validation and routine monitoring of the efficacy of cleaning processes within washers, Cleaning Indicators provide a fast visual evaluation of the process and can identify any potential sources of issues. This is to ensure that the cleaning process of surgical instruments is taking place properly.

We offer a diverse range of Cleaning Indicators manufactured by our UK exclusive partner Terragene. Our portfolio includes:

  • CDWA4 Splat Cleaning Indicator
  • CDWA3 Splat Cleaning Indicator
  • Lumenia SixFlow Endoscopy Process Challenge Device
  • IT27W-5 Thermodisinfection Indicator for moist heat disinfection
  • CD 29 multi-variable chemical indicator for Steam

PCD- Protein Residue testing 

We also offer Protein Residue Testing as an alternate form of Process Challenge Device. The test, comprised of an auto-reader incubator and a protein pen, is designed to detect residual levels of protein on the surface that is not otherwise identifiable by visual inspection.

Testing for proteins focuses on certain types of protein commonly present in blood and is an essential part of a hospital sterile services regulatory compliance.

To achieve full compliance with the latest HTM 01 – 01: 2016 for the decontamination of reusable surgical instruments, evidence of good practices is required, including logging evidence of each protein residue test carried out within the decontamination department as proof of a traceable process. In addition, Protein Residue Tests are essential to the day-to-day running of a sterile service department.

Our Protein Residue testing portfolio is comprised of three products- testing made easy!

  • MiniPro, an auto-reading incubator for protein residue testing
  • PRO1 MICRO, high sensitivity protein residue testing pens
  • PRO1 VT, a positive negative validation control kit

What Process Challenge devices do we offer? 

At Sychem, we offer a number of Process Challenge Devices, designed for use in autoclaves, washer disinfectors and other decontamination equipment.

Our vast portfolio spans Cleaning Indicators and Protein Residue Testing for use in washer disinfectors and Biological Indicators and Chemical Indicators designed for use in autoclaves.

Who are Terragene?

Our complete portfolio of Process Challenge Devices are manufactured by the Infection Prevention giant, Terragene. As the UK exclusive partner since 2017, Sychem and Terragene have worked together to support SSD departments across the UK.

chemical indicator Terragene process challenge devices

Our range of washer disinfectors

At Sychem, we also offer a complete portfolio of washer disinfectors manufactured by our partner Steelco, for use in Healthcare, Laboratory and Life Science facilities.

Discover our complete range of Infection Control consumables, Decontamination equipment and Equipment Servicing contracts, or contact a member of our expert team for more information.

Can’t find what you’re looking for? Visit the Terragene and Steelco websites for more information.


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